BEIJING, Sept. 8, 2022 /PRNewswire/ -- YishengBio Co., Ltd., ("YishengBio"), a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics, announced that the Company received the approvals from the regulatory authorities of United Arab Emirates (UAE) and the Philippines to conduct Phase 2/3 clinical trials for its PIKA recombinant COVID-19 vaccine. The phase 2/3 clinical trials will evaluate the immunogenicity, efficacy and safety of PIKA COVID-19 vaccine as a booster injection among subjects who received 2 or more doses of inactivated COVID-19 vaccine. The trials are designed to be multi-country, multi-center studies with the enrollment of 9,300 participants in UAE, Philippines and Pakistan.
PIKA recombinant COVID-19 vaccine is a highly differentiated vaccine candidate with potential prophylactic and therapeutic benefits against COVID-19 infection. PIKA recombinant COVID-19 vaccine is composed of PIKA adjuvant and S protein antigen by using genetic engineering technology with appropriate stabilizer. The pre-clinical studies demonstrated that this vaccine candidate is capable of sustaining two year long of high levels of neutralizing antibodies against a wide range of the variants of the COVID-19 virus, including Omicron BA.2, BA.4/5.
Based on the Phase 1 interim results of PIKA COVID-19 vaccine in UAE, the participants who received the low dose of 5 ug per injection were able to achieve high levels of neutralizing antibodies against all currently prevalent SARS-CoV-2 variants, including Omicron BA.2, BA.4/5, both in the prime vaccination regimen and booster dose for subjects who completed 2 doses of inactivated vaccines. PIKA COVID-19 vaccine candidate demonstrated good safety profile in phase 1 study.
"The initiation of the phase 2/3 clinical trials in multi countries will accelerate the clinical development of PIKA recombinant COVID-19 vaccine candidate to a new level," said Mr Yi Zhang, the Chairman and the Project Leader at YishengBio. "PIKA recombinant COVID-19 vaccine candidate achieved high levels of immunogenicity and broad neutralizing antibodies in clinical trials against wide range of SARS-CoV-2 virus strains, including the most prevalent Omicron variant. This vaccine candidate has the potential to become a universal vaccine against the swiftly mutating SARS-CoV-2 virus worldwide. Equally important, our newly constructed manufacturing plant dedicated to the commercialization of PIKA recombinant COVID-19 vaccine was recently granted the drug manufacturing certificate by the China's National Medical Products Administration (NMPA). We are excited about the initiation of this clinical study and eager to bring this valuable and highly differentiated vaccine to the public health arena to help address critical unmet medical needs."
About PIKA Technology:
PIKA technology is an immuno-modulating technology platform based on synthetic biologic complex which is originated from Yishengbio's proprietary research and GMP manufacturing engineering process. Through TLR3, RIG-I and MDA-5 signaling pathways, PIKA molecule can induce prompt production of interferon, cytokines, chemokines and co-stimulatory factors. PIKA administration facilitates antigen cross-presentation by dendritic cells and augments CD4+ T-cell, CD8+ T-cell and natural killer-cell responses. When delivered with relevant antigen-based molecules, PIKA technology can be applied to the development of a new generation of antiviral vaccines, antiviral and anticancer therapeutics, offering a promising platform for the development of a wide variety of novel biologics to improve treatments that are currently available and address unmet medical needs.
YishengBio is a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generation of vaccines and therapeutic biologics for infectious diseases and cancer. YishengBio is expanding its business horizon with a global footprint across various countries, including China, United States, Singapore, the Philippines, Pakistan, the UAE and other countries. The Company has developed proprietary PIKA immunomodulating technology platform which augments both innate and adaptive immune responses through the TLR3, RIG-I and MDA5 pathways. PIKA technology platform has empowered and nurtured a diverse and innovative pipeline of vaccines and therapeutic biologics with differentiated efficacy and safety profile to address the unmet medical needs in infectious disease and oncology.
YishengBio is one of the leading suppliers of human rabies vaccine in Chinese market and its development pipeline includes PIKA Rabies Vaccine, PIKA recombinant COVID-19 Vaccine, YS-HBV-001, YS-HBV-002 and YS-ON-001 targeting various prophylactic and therapeutic indications. YishengBio is headquartered in Beijing and has over 800 employees in China, U.S.A, Singapore and other countries in Asia. For more information on YishengBio, please visit www.yishengbio.com.